Recent Section 8 Damages Decisions of the Federal Court of Canada

Last month, the Federal Court of Canada released several decisions that addressed various issues pertaining to section 8 of the Patented Medicines (Notice of Compliance) Regulations (Regulations). Section 8 of the Regulations provides that a branded manufacturer is liable to a generic manufacturer for damages attributed to a delay in market entry caused by the commencement of an unsuccessful prohibition proceeding. Each of the following decisions was released last month:

• Apotex Inc v Sanofi-Aventis, 2012 FC 553, which addressed the quantification of Apotex Inc’s (Apotex) section 8 damage claim against Sanofi-Aventis Canada Inc and its related companies (Sanofi), regarding the drug ramipril (Apotex Ramipril);
• Sanofi-Aventis Canada Inc v Teva Canada Limited, 2012 FC 552, which addressed the quantification of Teva Canada Limited’s (Teva) section 8 damage claim against Sanofi regarding the drug ramipril (Teva Ramipril);
• Sanofi-Aventis Canada Inc v Teva Canada Limited, 2012 FC 551, which addressed claims of invalidity of section 8, which were raised by Sanofi as a defence to Apotex’s and Teva’s above-mentioned ramipril damage claims (Ramipril Validity);
• Apotex Inc v AstraZeneca Canada Inc, 2012 FC 559, which dealt with the issue whether Apotex was entitled to claim section 8 damages against AstraZeneca Canada Inc (AstraZeneca) regarding omeprazole and whether section 8 was valid legislation (Apotex Ompeprazole); and
• Apotex Inc v Merck & Co Inc, 2012 FC 620, which determined the relevant period for Apotex’s section 8 damage claim against Merck & Co Inc and its related companies (Merck) regarding lovastatin, and assessed whether the defence of ex turpi causa was available to Merck (Merck Lovastatin).

These decisions further affirmed the validity of section 8 of the Regulations and shed light on how damages are to be quantified. For an extended discussion of the five decisions, click here. Summary by: Michael Migus